Hypertrophic Scar Clinical Trial
— NFWHSFOfficial title:
Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | March 1, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - scheduled for DIEP-flap breast reconstruction surgery at our department Exclusion Criteria: - smokers - use of cortisone or other immunsuppressants - diabetes mellitus type 1 or 2 - age - connective tissue disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale | The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery | one year | |
Primary | Clinical assessment of the time to healing of the abdominal wound | The time for the abdominal wound to heal will be registered. Wound healing is considered a closed and non-dehiscent wound witout signs of inflammation or infection. | one month | |
Primary | Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar. | Evaluation of the histological differences of the treatment arm vs. control, by evaluating scar properties on tissue biopsy. Scar thickness, collagen arrangement and angiogenesis will be evaluated. | six months | |
Primary | Pigmentation Index of the two sides of the scar, measured with a Mexameter | Evaluation of the Pigmentation Index difference in the treatment arm vs. control arm will be measured by the use of a mexameter, starting from one month after the procedure (after wound healing is complete). | one year | |
Primary | Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale | Evaluation of patient satisfaction over the entire course of the study by filling in a Visual Analog Scale, with 1 being very unsatisfied and 10 being very satisfied. | one year | |
Primary | Rate of adverse events | Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar | One year |
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